tbuckley/cabot-search huggingface dataset:
Factors predicting pathological complete response in patients with localized breast cancer receiving neoadjuvant chemotherapy.
Authors: Arya Mariam Roy, Kristopher Attwood, Shipra Gandhi
Journal: Journal of Clinical Oncology (2022)

165 Background: Pathological Complete Response (pCR) after Neoadjuvant Chemotherapy (NAC) is associated with improved survival outcomes in early-stage breast cancer. However, data regarding the factors predicting pCR are limited. We analyzed the clinical and pathological factors associated with the attainment of pCR after NAC. Methods: We queried National Cancer Database for non-metastatic breast cancer patients who received NAC between 2010 and 2016. All associations were compared using Kruskal-Wallis, Pearson’s Chi-Squared, and Fisher’s Exact Tests. Multivariate logistic models were used to analyze association of race, sub-type, age, clinical stage, grade, histology, insurance, comorbidity index with pCR. Odds ratios, 95% confidence intervals, and p-values for each predictor were recorded and adjusted for confounders. All analyses were conducted in RStudio v4.0.2 at a significance level of 0.05. Results: A total of 137140 female and 741 male patients were identified. Majority of the patients were Whites (n = 95909) followed by Blacks (n = 23736), and Hispanics (n = 11023). 58.4% (n = 80556) patients were &gt; 55 years. 64% of the patients had private insurance, 31.1% (n = 42930) had government insurance (Medicare and Medicaid) and 3.6% (n = 4904) were uninsured. Majority of the patients had Charlson comorbidity index (CCI) equal to 0 (87%). Hormone-receptor positive and HER2 negative (HR+HER2-) comprised 37.9% (n = 51283), HER2+ were 35.2% (n = 47794) and triple-negative breast cancer (TNBC) were 26.9% (n = 36401). Compared to TNBC, HER2+ had higher and HR+HER2- had lower chance of attaining pCR. Blacks had lower (OR = 0.95, p &lt; 0.001) and Hispanics had higher chance of pCR (OR = 1.1 p &lt; 0.001) when compared to Whites in the overall population which includes all subtypes. Younger patients had lower chance of attaining pCR compared to elderly. Stage I and II patients had more chance of PCR compared to stage III. Patients with government insurance had lower odds of attaining PCR compared to those with private insurance. Patients with CCI 0 had higher chance of pCR when compared to those with CCI &gt; = 3 (OR = 1.15, 95% CI = 1.08-1.2, p &lt; 0.001). Conclusions: Patient and tumor factors play an important role in response to NAC in breast cancer patients. Identifying modifiable factors associated with odds of lower pCR rates such as, government insurance would help us intervene to improve the quality of care of breast cancer patients.[Table: see text]
Comparing chair time required for systemic agent drug reaction (DR) management to allocated chair time for systemic protocol.
Authors: Jennifer Marie Rauw, Helen Anderson, Sunil Parimi, Michelle Brown, Kathleen Hennessy
Journal: Journal of Clinical Oncology (2022)

40 Background: Chemotherapy scheduling and determining associated nursing resources are complex multiobjective decision problems. Management of DRs are thought to take additional chair and nurse time and should be accounted for in appointment scheduling in order to having an efficiently running clinic. BC Cancer – Victoria is a tertiary care regional site of BC Cancer in Victoria, British Columbia, Canada and currently schedules patients using a regimen-based resource intensity model (Greene et al, 2012). Methods: DRs were tracked in real time over 3 months, where BC Cancer ID, reaction, protocol, agent, cycle number and time of reaction were recorded. Our electronic medical record was interrogated to determine start and end of chair time. We then compared the actual chair time required to manage patients with a DR to scheduled chair time. Results: Thirty reactions occurred, including DRs to paclitaxel (43%), rituximab (13%), docetaxel (10%), nivolumab (7%), oxaliplatin (7%), pertuzumab (7%), bendmustine (3%), and daratumumab (3%). The reactions most commonly occurred with cycles 1 or 2. The averages for total chair time during DR, time from arrival to reaction, and time from reaction to discharge were 281 min (+79.5), 106 min (+ 55), and 171 min (+ 94), respectively. An average of 449 min/month extra were required for DR management above scheduled chair time. Conclusions: The agents precipitating DRs were common and predictable. An average of 7 hours and 29 minutes per month above scheduled chair time was required to manage DRs. This information could be used to more efficiently schedule chair and nursing time. This also highlights the need to minimize the number of DRs as management is resource intensive.[Table: see text]
Single-center comparison of cancer genetics referral rates for patients with pancreatic cancer following implementation of a best practice advisory: A quality improvement project.
Authors: Stephanie Rivera Morales, Ian Dale, Kristin Mattie, Brooke Levin, Jamin C. Morrison, Jenia Jenab-Wolcott
Journal: Journal of Clinical Oncology (2022)

311 Background: Despite guidelines recommending germline genetic testing (GT) and genetic counseling for individuals with pancreatic ductal adenocarcinoma (PDAC), referrals remain suboptimal. This can have negative implications on treatment, particularly for patients with actionable mutations. This project aims to compare the referral rate to genetic services of MD Anderson Cancer Center at Cooper pre- and post-implementation of an electronic health record (EHR) physician best practice advisory (BPA) recommending a cancer genetics referral order for PDAC patients. Methods: Medical records, cancer genetics referrals (CGR), and germline and somatic testing results were retrospectively reviewed for patients with a PDAC diagnosis in 2019-2020, and prospectively for those diagnosed after BPA implementation from October 2021 through May 2022. The primary outcome was the rate of CGR, and the secondary outcomes were genetic counseling encounters and GT completion. Descriptive statistics were used for analysis. Results: Prior to BPA initiation, CGR were offered to 44 (24.3%) of 181 eligible patients with 39 (88.6%) of those accepting CGR. Germline testing represented 90.9% (30 patients) of the GT performed in the pre-BPA group. Post-BPA, CGR were offered to 23 (51.1%) of 45 eligible patients with 20 (86.95%) of those accepting CGR. Germline testing represented 100% (13 patients) of the GT performed in the post-BPA group. Conclusions: Only 24.3% of patients diagnosed with PDAC between 2019-2020 were referred to cancer genetics, showing that even after updated NCCN guidelines in 2018 the CGR rate remained low. Following BPA implementation, CGR increased to 51.1% over 8 months for newly diagnosed patients. Germline testing increased by 10%. These preliminary results show that implementing a physician BPA can increase CGR and germline GT, which could have positive implications on treatment. Limitations include a lack of a standardized referral process for the pre-BPA group and a limited timeframe to obtain GT for the post-BPA group.[Table: see text]
What’s missing? Diagnostic workup for breast cancer in Sudan.
Authors: Noon Eltoum, Nicole E. Caston, Lily Gutnik, Mahmoud A. Alfardous Alazm, Feras Omer Mohamed, Lama Mahjoub Abdalkarem, Saad Ahmed Saad, Abrar Z. Badawi, Nicole Henderson, Andres Azuero, Gabrielle Betty Rocque
Journal: Journal of Clinical Oncology (2022)

110 Background: In Sudan, healthcare access may limit diagnostic workup for breast cancer. This study evaluates the relationship between geography and ethnicity and completeness of documentation of diagnostic workup (staging and receptor testing) in Sudan. Methods: This retrospective study used data abstracted from patients with breast cancer receiving cancer care at Sudan’s largest cancer center (Radiation and Isotopes Center Khartoum [RICK]) in 2017. The patient’s age at diagnosis, sex, breast cancer stage, ethnic subgroup (further categorized as Arab and non-Arab), regions of origin and residence (Central, Northeastern, Western, and Khartoum [where RICK is located]), and receptor status from pathology reports were abstracted from paper medical records. Complete diagnostic workup was defined as having both receptor testing and staging. Descriptive statistics were calculated using frequencies and percentages for categorical variables and median and interquartile range (IQR) for continuous variables. Odds ratios (OR) and 95% confidence intervals (CI) were estimated to evaluate complete diagnostic workup on ethnic group, origin, and residence using binomial logistic regression models (excluding non-Sudanese patients and those with missing demographics). Results: Of 240 patients included, 237 were female, median age was 53 (IQR 43-62). Most often patients were Arab (68%), originated from Northeastern and Khartoum regions (both 28%) and lived in the Khartoum region (53%). Overall, 49% patients were missing receptor testing and/or staging, with modest differences by geographic region and ethnicity (Table). In adjusted analyses, non-Arab patients had similar odds of having complete diagnostic workup when compared to Arab patients (OR 1.22; 95% CI 0.70-2.10). Patients originating from and residing in regions outside the Khartoum region had similar odds of complete diagnostic workup when compared to patients originating from and residing in the Khartoum region. Conclusions: Almost half of breast cancer patients had incomplete diagnostic workup, regardless of region of origin, region of residence, and ethnic group. This highlights a substantial systems-based quality gap in care delivery, warranting efforts to improve completeness in diagnostic workup for all patients with breast cancer in Sudan.[Table: see text]
Racial/ethnic disparities in HPV-associated anogenital cancers among males in the United States (2005-2016): A population-based retrospective cohort study.
Authors: Seiichi Villalona, Simone Sukhdeo, Daisy Reinoso, Antoinette Stroup, Jeanne Ferrante
Journal: Journal of Clinical Oncology (2022)

163 Background: Among the HPV-associated cancers, research has primarily focused on understanding prevention and outcomes among females with cervical cancer. Limited data is available on health outcomes of male HPV-associated anogenital cancers, particularly among racial/ethnic minority groups. Methods: This population-based retrospective cohort study included 39,601 males diagnosed with HPV-associated invasive penile and anorectal cancers between 2005-2016 in the North American Association of Central Cancer Registries. Outcomes included: age-adjusted incidence, late-stage diagnosis, survival, and cancer-specific mortality. We evaluated association of race/ethnicity with outcomes using multivariable logistic regression, adjusted survival curves, and Cox proportional hazard modeling, adjusting for age, insurance, residential characteristics (metropolitan/non-metropolitan, area poverty, and geographic region), stage, and treatment. Results: Hispanic and Non-Hispanic (NH) Black males had the highest age-adjusted incidence of penile and anorectal cancer, respectively. Higher odds of late-stage penile cancer were observed among NH Black (adjusted odds ratios [aOR] 1.22, 95% CI 1.07-1.39) and Hispanic males (aOR 1.17, 95% CI 1.04-1.31). Higher odds of late-stage anorectal cancer were observed among NH Black (aOR 1.25, 95% CI 1.14-1.36) and NH Other males (aOR 1.29, 95% CI 1.01-1.66). Compared to all other groups, NH Black males had the lowest cumulative and mean survival of both cancers and higher cancer-specific mortality (penile adjusted hazards ratios [aHR] 1.23, 95% CI 1.01-1.49; anorectal aHR 1.25, 95% CI 1.10-1.42). Adjusting for treatment attenuated associations but did not eliminate the observed cancer-specific mortality. Conclusions: Hispanic males had the highest incidence of penile cancer and were diagnosed at later stages than non-Hispanic (NH) White counterparts. NH Black males had the highest incidence of anorectal cancers, and regardless of anatomic site, they had the highest rates of late-stage diagnosis and mortality even when controlling for all other covariates, including treatment. The findings highlight the necessity of interventions to increase HPV vaccination rates, early detection, and treatment of anogenital cancers in males, particularly among men of color.
Utilization of the Khorana score (KS) by hematology/oncology clinicians in the ambulatory setting.
Authors: Megan Emmich, Neiha Kidwai, Lisa Holle, Ritika Vankina
Journal: Journal of Clinical Oncology (2022)

31 Background: Patients with cancer are at an increased risk for venous thromboembolism (VTE). Though cancer-associated thrombosis is a major cause of mortality in patients, only second to disease progression, the optimal use of primary prophylaxis remains a clinical challenge. The KS, developed in 2008, is a validated tool to identify patients at low, intermediate, and high-risk for VTE. At the UConn Health Neag Comprehensive Cancer Center, we created a survey and administered it amongst our clinicians to assess KS knowledge and documentation practices. Methods: We conducted a 3-part quality improvement study that included a pre- and post-intervention retrospective chart review of eligible patients with cancer to examine rates of KS documentation. Eligibility included patients with cancer initiating a new chemotherapy. We excluded patients on anticoagulation, multiple myeloma, brain/central nervous system tumors, and patients in the Department of Corrections. The interventions included: 1) 9-question survey to assess clinician knowledge and utilization of KS; 2) KS education presented at a clinician meeting; 3) an electronic medical record (EMR) tool implemented to standardize KS documentation; and 4) reminder KS tip sheet created for clinicians. Descriptive statistics were used in data analysis. Results: Of 50 documented encounters, 40 met study criteria, with none having KS documentation. In a pre-tool implementation survey sent to 24 clinicians, of whom 20 had participated, 70% were physicians, 30% were advanced practice registered nurses (APRN), and 60% reported being in practice for 5 years or less. Most (90%) reported not using KS; only 10% reported being unfamiliar with the KS while 65% reported only sometimes talking to patients about VTE risk. Of the 10% of clinicians that did document KS, it was reported that they “document in the narrative of [the] note when appropriate.” The highest barriers to documentation were reported as “time constraints with extra documentation” and “not enough guidance.” Post-EMR tool implementation, a total of 58 of 99 (58.5%) encounters met study criteria and 1 KS was documented (1.7%). Conclusions: KS is underutilized in ambulatory clinical settings partly due to a lack of education and awareness despite availability of national guidelines which reflect the importance of primary VTE prophylaxis evaluation in all patients with cancer. This study demonstrates a continued deficiency in our clinical practice. We aim to further identify barriers and methods for improvement of KS documentation and VTE risk assessments. Additionally, a referral process is planned for all at-risk patients to enhance patient care, decrease hospital visits related to VTE, and attempt to reduce health-care costs related to VTE care.
Treatment patterns, clinical outcomes, and costs following the approval of new systemic therapy medications for hepatocellular carcinoma.
Authors: Timothy Pham, Aliza Gordon, David Joseph Debono, Michael Jordan Fisch
Journal: Journal of Clinical Oncology (2022)

398 Background: Between March 2017 and May 2020, ten new systemic medication therapies for hepatocellular carcinoma (HCC) were approved for the US market. However, clinical trials for medications only showed marginal improvement in health outcomes compared to placebo or sorafenib, the only medication previously approved for HCC. The objective of this study was to examine the change in treatment patterns and outcomes of incident patients with HCC before and after multiple medication approvals. Methods: This observational cohort study used administrative medical and pharmacy claims data for adult commercially insured and Medicare Advantage patients with at least two diagnoses of HCC during July 2013 to December 2020. Patients were categorized into two groups: the pre-approval group (identified between July 2013 and March 2017) and the post-approval group (identified between April 2017 and December 2020). We compared systemic therapy treatment (e.g., sorafenib and lenvatinib) patterns, survival, hospitalization for serious infections, other treatments such as G-CSF use and liver transplants, and cost (e.g, total all-cause costs and anti-HCC systemic therapy). Generalized linear model and Cox proportional hazards regression were used to assess the effect of new approvals on outcomes while controlling for baseline characteristics. Results: We identified 2,730 patients in the pre-approval group and 2,290 patients in the post-approval group. After risk adjustment, the latter was more likely to use systemic therapy medications (20.4% vs. 13.7%, adjusted odds ratio [aOR] 1.41, 95% confidence interval [CI] 1.22-1.62). Overall survival remained similar between the two groups (adjusted hazard ratio [HR] 0.96, 95% CI 0.87-1.06) and among the subsets who used systemic therapy (aHR 1.10, 95% CI 0.91-1.32). Odds of liver transplant (aOR 1.03, 95% CI 0.80-1.34) and hospitalization for serious infections (aOR 0.95, 95% CI 0.87-1.09) were similar, while the post-approval group had lower odds of G-CSF use (aOR 0.59, 95% CI 0.48-0.73). No differences in total per-member-per-month (PMPM) costs were seen, but the post-approval group had lower PMPM pharmacy-related costs (adj cost diff -$1,188, 95% CI -$1,575 to -$755) and higher PMPM systemic therapy costs (adj cost diff $971, 95% CI $584 to $1446). Conclusions: As expected, use of newer systemic therapies in HCC patients increased following approval of new medications. However, there was no associated change in clinical outcomes such as survival or serious infections, providing additional real-world evidence of marginal improvement, if any. Pharmacy costs decreased in the post-approval group, which may reflect a shift from oral sorafenib to newer injectable systemic therapies.
Investigating keratinocyte growth factor hair serum for the prevention of chemotherapy-induced alopecia.
Authors: Preethika Potluri, Emma Elizabeth Paul, Jennifer Margaret Segar, Sima Ehsani, Sao Jiralerspong, Denise Roe, Pavani Chalasani
Journal: Journal of Clinical Oncology (2022)

240 Background: Chemotherapy induced alopecia (CIA) is known to have a significant psychological and quality of life impact, mainly in women. While cold caps have been shown to decrease CIA, expense, availability, and extension of treatment durations are barriers for routine clinical use. Keratinocyte Growth Factor (KGF) has been shown to have cytoprotective effects on human keratinocytes in vitro and reduce apoptosis in human hair follicles. Based on this data, we hypothesized that KGF-Hair serum (KGF-HS) will prevent CIA in women undergoing chemotherapy as treatment for breast cancer. Methods: We designed a Simon 2-stage prospective study to test our hypothesis. Study was approved by our institutional review board and registered on clinicaltrials.gov (NCT04554732). In part 1 we planned to enroll 20 patients into a single arm. If ≥ 4 responses are noted, we proposed to initiate part 2: randomized double-blind placebo-controlled study. Patients with early-stage breast cancer (ESBC) who were scheduled to get at least 4 cycles of anthracycline or taxane based chemotherapy were included. Patients with inflammatory scalp conditions, hair loss disorder, scalp disorders were excluded. The primary endpoint was successful hair preservation using the Common Terminology Criteria for Adverse Events 4.0 scale at the end of 4 cycles of chemotherapy. Secondary end points included wig use and scores on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire–Core 30, Hospital Anxiety and Depression Scale, and a summary scale of the Body Image Scale. Results: Twenty patients completed part 1 of the study and were evaluable for primary endpoint. Mean age was 60 years and 70% were treated with taxane based chemotherapy. Successful hair preservation was noted in 0 of 20 women. Mean duration of treatment with KGF-HS was 4.6wks (range 2-10 weeks) before women came off study due to grade 2 hair loss. There were no statistically significant differences in changes in any of the scales of quality of life from baseline to end of treatment. There were only 2 grade 1 events (1 rash and 1 itching) reported which resolved after coming off the KGF-HS. There were no serious adverse device events. Conclusions: Among women with early-stage breast cancer receiving chemotherapy with a taxane, anthracycline, or both, using KGF-HS did not prevent CIA. Further research is needed to investigated other novel topical options to prevent CIA. Clinical trial information: NCT04554732.
One-year mortality and varying ascertainment windows for a Medicare claims-based proxy for frailty in women with stage I-III breast cancer.
Authors: Emilie Danielle Duchesneau, Til Sturmer, Dae Hyun Kim, Michele Jonsson Funk, Charles Poole, Alan C Kinlaw, Keturah R Faurot, Qoua L Her, Tiansheng Wang, Jennifer Leigh Lund
Journal: Journal of Clinical Oncology (2022)

396 Background: Frail cancer patients are more likely to die or experience treatment toxicity than non-frail patients. The Faurot frailty index (FFI) is a validated Medicare claims-based proxy that predicts frailty in individuals. Frailty is dynamic and can change over time. We assessed the distribution of the FFI and associations with 1-year mortality using varying durations of frailty ascertainment windows in breast cancer patients. Methods: We identified women (66+ yrs) with stage I-III breast cancer in the SEER-Medicare database who had ≥1 year of continuous enrollment in Medicare Parts A and B prior to diagnosis. The FFI-predicted probability of frailty was assessed using demographic and diagnostic and procedural billing information during varying pre-diagnosis ascertainment windows: 3, 6, 8, or 12 months or using all available pre-diagnosis claims. We described the distributions of the claims-based frailty measures using each of the five ascertainment windows and reported 1-year mortality for individuals with high (≥0.20), medium (0.05 - &lt; 0.20), or low (&lt; 0.05) claims-based frailty using Kaplan-Meier analysis. Follow-up began on the date of cancer diagnosis. Results: We identified 235,145 women with breast cancer. Using a 3-month ascertainment window, 76%, 20%, and 4% were classified as having low, medium, and high claims-based frailty. Although the distributions of claims-based frailty were similar using 3, 6, 8, and 12-month frailty ascertainment windows, the use of all available lookback led a wider interquartile range (IQR) for claims-based frailty (Table). Overall, 4% of women died within 1 year of diagnosis. Higher claims-based frailty was strongly associated with increased 1-year mortality risk, using each ascertainment window. Mortality associations were strongest with a 3-month ascertainment window: risk difference (RD) high vs. low frailty 20% (95% CI, 19-20%). Associations were weakest with an all available lookback window: RD high vs. low frailty 11% (95% CI, 11-12%). Conclusions: Varying frailty ascertainment window durations did not lead to substantial differences in the distribution of the FFI in women with stage I-III breast cancer. Associations between the FFI and 1-year mortality monotonically decreased with increasing ascertainment window durations. This may be due to claims in the distant past having less etiological relevance for predicting mortality during the year following cancer diagnosis.[Table: see text]